Wed.Nov 04, 2020

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Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma

Bio Pharma Dive

Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson.

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Misinformation and confusion: Online health seekers

World of DTC Marketing

THE SHORT : The confusion around the Presidential election, which is ongoing at the time of this post, has a lot of similarities with online health information. As social media becomes a bigger part of information gathering for health seekers they are often making bad treatment decisions based on what they read. According to Annual Review “in general, we do not have the cognitive capacity, motivation, or time to evaluate all the information that we encounter online.

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Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval

Bio Pharma Dive

Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab.

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Stage 4 Breast Cancer Treatment in Germany

Pharma Mirror

To date, breast cancer is one of the most dangerous diseases. Unfortunately, it is not always possible to diagnose it early due to the lack of modern equipment in many countries. Medical tourism is getting popular, and you can easily get stage 4 breast cancer treatment in Germany. Modern hospitals in Germany have the most. The post Stage 4 Breast Cancer Treatment in Germany appeared first on Pharma Mirror Magazine.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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The ‘failure’ of clinical trials in the search for COVID-19 treatments

pharmaphorum

Professor Jean-Pierre Boissel outlines the urgent need for disruptive R&D approaches that can tackle the search for COVID-19 treatments more effectively. It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. For the purposes of this text, let us assume that ‘success’ and ‘failure’ will be used in reference to the objective of clinical trial designers: to obtain sufficient evidenc

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Abbott Sues Former VP Over Trade Secrets, Similar Cases Expected to Follow in “New Normal”

BioSpace

Abbott is suing their former VP Jerome Clavel over allegations of trade secret theft with intent to share with his new employer, rival diagnostics company Bio-Rad.

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Allogene’s Off-the-Shelf Myeloma CAR-T Data Marred by Patient Death

BioSpace

South San Francisco-based Allogene Therapeutics released some early data from its Phase I UNIVERSAL clinical trial of ALLO-715 for relapsed/refractory multiple myeloma.

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Scientists develop method to detect charge traps in organic semiconductors

Scienmag

Scientists at Swansea University have developed a very sensitive method to detect the tiny signatures of so called ‘charge traps’ in organic semiconductors Credit: Swansea University Scientists at Swansea University have developed a very sensitive method to detect the tiny signatures of so called ‘charge traps’ in organic semiconductors.

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Logistics and Efficacy Challenges Force World to Pivot Against COVID-19

BioSpace

When it comes to a novel virus like SARS-CoV2, a certain amount of “rolling with the punches” is required, and governments and global organizations like the World Health Organization are beginning to dismiss certain treatments and devote themselves wholeheartedly to others.

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SLAC, Stanford to host national service center for cryo-ET sample preparation

Scienmag

The center complements other NIH centers at SLAC and elsewhere that broaden access to this cutting-edge technology for biomedical research Credit: Jesús G. Galaz-Montoya and Kirk Czymmek The National Institutes of Health is establishing a national service center at the DOE’s SLAC National Accelerator Laboratory and Stanford University where biomedical researchers can learn how to […].

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Novartis’ Aimovig tops topiramate in migraine face-off

pharmaphorum

Novartis’ injectable migraine prevention antibody Aimovig has been shown to be more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial. The HER-MES trial found that Aimovig (erenumab) was more effective at preventing migraine attacks and also better tolerated than topiramate, a generic epilepsy drug which is known to have side effects like sleepiness, dizziness, diarrhoea and nausea.

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Monitoring open-cast mines better than before

Scienmag

New radar satellites allow observation in almost real time Credit: Wei Tang, Mahdi Motagh, Wei Zhan When it comes to safety in open-cast mining, soil stability is one of the most critical factors. Settlement of the ground or slipping of slopes poses a great risk to buildings and people. Now Mahdi Motagh from the German […].

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Kyowa Kirin backs €125m life science fund closed by Fountain Healthcare

pharmaphorum

Ireland-based Fountain Healthcare Partners has raised another €125 million ($131 million) for its third life sciences fund – 25% ahead of its target – and says it will pump most of the money into European therapeutics and medical device companies. The latest cash injection adds to the €118 million initially raised by Fountain Healthcare for the fund in May 2019, and brings the total value managed by the company above the €300 million mark.

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Case study details leukemia patient who shed infectious SARS-CoV-2 for at least 70 days

Scienmag

Credit: NIAID-RML The majority of people infected with SARS-CoV-2 appear to actively shed infectious virus for about 8 days, but there is a wide range of variability from person to person. Understanding how long people can remain actively infected is important, because it provides new details about a disease and a virus that are still […].

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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DARPA selects continuous manufacturing partner

Outsourcing Pharma

The agency has chosen Continuity Pharma to aid in development and advancement of continuous manufacturing technology, with the help of a $1.5m grant.

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Nature-inspired solutions to sustainably increase crop yield

Scienmag

The 5-year 8M € project GAIN4CROPS aims to improve photosynthetic efficiency of the oil crop sunflower using nature-inspired solutions and innovative breeding techniques. Credit: Photo by Sirr Snow on Unsplash GAIN4CROPS is developing novel disruptive technologies to overcome one of the main constraints of photosynthesis: the photorespiration, a process that reduces CO2 assimilation efficiency, and […].

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BioSpace Global Roundup, Nov. 5

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

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The biggest trees capture the most carbon: Large trees dominate carbon storage in forests

Scienmag

Large-diameter trees make up 3% of total stems, but account for 42% of total carbon storage in Pacific Northwest forest ecosystems Credit: The authors Older, large-diameter trees have been shown to store disproportionally massive amounts of carbon compared to smaller trees, highlighting their importance in mitigating climate change, according to a new study in Frontiers […].

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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DFE Pharma: adoption of continuous manufacturing on the rise

Outsourcing Pharma

According to representatives from the pharma solutions provider, incorporation of CM processes, after a slow period, is expanding across the industry.

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Fighting Zika? Call in the T cells

Scienmag

Stopping emerging viruses could depend on getting T cells and antibodies to work together Credit: NIAID LA JOLLA–Where Aedes mosquitoes fly, Zika virus may not be far behind. Although the explosive 2015-2016 Zika epidemics in the Americas are behind us, Zika may re-emerge, and “in many countries, Zika may be spreading in silence,” says Sujan […].

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Top 25 Women Leaders in Biotech: Female Execs Paving the Way for Innovation

BioSpace

The Healthcare Technology Report announced on Nov. 3 its list of the Top 25 Women Leaders in Biotechnology of 2020.

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Society of Asian Scientists and Engineers names Sandia Labs Organization of the Year

Scienmag

Sandia computer scientist also bestowed Professional Achievement Award Credit: Photo by Randy Montoya ALBUQUERQUE, N.M. — Sandia National Laboratories has been named 2020 Organization of the Year in the government category by the Society of Asian Scientists and Engineers. The award, presented during the society’s virtual conference this month, recognizes organizations with a longstanding commitment […].

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Can Pharma Win Back America?

BioSpace

According to recent polls, less than half of Americans trust pharmaceutical companies. In fact, only 42% of respondents say they have any trust in pharma, with a paltry 6% having a great deal.

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When plants attack: parasitic plants use ethylene as a host invasion signal

Scienmag

Researchers from Nara Institute of Science and Technology find that the plant hormone ethylene mediates the invasion of hosts by parasitic plants Credit: Satoko Yoshida Nara, Japan – Mutants that reveal the secrets of how plants attack? No, it’s not a scene from a science fiction movie, but you could be forgiven for thinking that. […].

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Hired and retired: Appointments at the top

BioPharma Reporter

While all eyes are on a certain top job in the US at the moment, the biopharmaceutical industry is also looking at its leaders.

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New form of brain-training helps prevent relapse after alcohol treatment

Scienmag

Credit: (C) Turning Point A recent study has shown that it may be possible to dampen the workings of the subconscious brain to prevent alcohol relapse, the results leading to a world-first trial of a personalised smartphone app called “SWiPE” Cognitive Bias Modification, a new form of computerised brain-training, is focused on training the brain […].

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Q3 Reports: AbbVie, BMS, Allogene, Gilead and AstraZeneca

BioSpace

It’s a busy time of year for the biopharma industry, as most companies have begun reporting third-quarter financials.

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Building a quantum network one node at a time

Scienmag

Credit: University of Rochester illustration / Michael Osadciw Researchers at the University of Rochester and Cornell University have taken an important step toward developing a communications network that exchanges information across long distances by using photons, mass-less measures of light that are key elements of quantum computing and quantum communications systems.

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FDA Places New CMC Demands on bluebird's Sickle Cell Treatment

BioSpace

The company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration for two more years.

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The first duckbill dinosaur fossil from Africa hints at how dinosaurs once crossed oceans

Scienmag

Credit: Credit: Raul Martin The first fossils of a duckbilled dinosaur have been discovered in Africa, suggesting dinosaurs crossed hundreds of kilometres of open water to get there. The study, published in Cretaceous Research, reports the new dinosaur, Ajnabia odysseus, from rocks in Morocco dating to the end of the Cretaceous, 66 million years ago. […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.